Recently errors in billing for combinations of custom–fabricated orthotic additions with prefabricated base orthoses have been identified.

The Coding Guideline sections of the policy article for AFO/KAFO define prefabricated and custom-fabricated as follows:

A prefabricated orthosis is one, which is manufactured in quantity without a specific beneficiary in mind. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary (i.e., custom fitted). An orthosis that is assembled from prefabricated components is considered prefabricated. Any orthosis that does not meet the definition of a custom-fabricated orthosis is considered prefabricated.

A custom-fabricated orthosis is one, which is individually made for a specific beneficiary starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work such as cutting, bending, molding, sewing, etc. It may involve the incorporation of some prefabricated components. It involves more than trimming, bending, or making other modifications to a substantially prefabricated item.

It is inherent in the definition of prefabricated that a particular item is complete. Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and will be denied as not reasonable and necessary if billed with prefabricated base orthotics. Refer to the LCD for ankle-foot/knee-ankle-foot orthoses for additional information about coverage, documentation and billing for these items.